Shockwave Treatment of Diabetic Foot Ulcer. A Prospective, Controlled, Randomized Trial. Step 1
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Percentage decrease of ulcer size twelve weeks after treatment begin (i.e. first shock wave treatment) compared to the baseline (ulcer size at first treatment)
研究概览
简要总结
Extracorporeal Shock Wave treatment is a well established treatment in orthopedics. Considerable success has been reported after treatment of various soft tissue pathologies (Tendinitis, heel spur etc). In recent years, encouraging results have been reported concerning the effect of the shock-wave on chronic wounds. It has been reported that healing time can be considerably shortened if shock-waves are applied to the wound in addition to conventional wound treatment. Yet, randomized, controlled, prospective trials are missing.
In this study, the effect of shock-waves on diabetic foot ulcer shall be assessed.
The study is composed of 5 groups of which 4 groups receive shock wave treatments (each with a different protocol). One group serves as an untreated control group. All groups get standardized wound treatment and wound dressing.
That shock-wave application protocol that shows the best results (rate of completely healed ulcer, most decrease of ulcer size) shall be tested in a further, sufficiently dimensioned, two-armed, randomized controlled trial (RCT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 and older
- •Diabetes Type I or II
- •Chronic ulcer on the foot
- •Ulcer present for at least 6 weeks
- •Wagner Grade 1 or 2
排除标准
- •Chronic rest pain
- •Critical ischemia
- •Ankle-Arm-Index < 0,5
- •Critical ischemia treated within 6 weeks before possible enrollment
- •Ulcer of Grade 3 or worse according to the Wagner Classification
- •Osteomyelitis
- •Affection of toes
- •Necessity of surgical intervention
- •Malalignment of the foot sustaining the ulcer
- •Treatment of Ulcer with Prostaglandins or vasodilatators within the last 2 weeks
- •Current therapy with corticoids
- •Infection with HIV; Hepatitis
- •Suppression of immune system (due to illness or medication)
- •Medication with Vitamin-K-Antagonists
- •Known hemophilia
- •Sever Hypalbuminemia < 2 g/dl
- •Severe anemia
- •Ulcer other than of diabetic origin
- •Pregnant or breast-feeding women
- •Known coagulopathies
- •Implants such as artificial heart valves, joint replacement, bone replacement, osteosynthesis material
- •Patients participating on other studies
- •Chemotherapy within the last 60 days
- •Mentally disabled patients
研究组 & 干预措施
Group I
干预措施: Extracorporeal Shock Wave (Procedure)
Group II
干预措施: Extracorporeal Shock Wave (Procedure)
Group III
干预措施: Extracorporeal Shock Wave (Procedure)
Group IV
干预措施: Extracorporeal Shock Wave (Procedure)
Group V
结局指标
主要结局
Percentage decrease of ulcer size twelve weeks after treatment begin (i.e. first shock wave treatment) compared to the baseline (ulcer size at first treatment)
次要结局
- Rate of completely healed ulcer 6, 9 and 12 weeks after first treatment
- Percentage decrease of ulcer size 6 and 9 weeks after first treatment
- Tissue oxygen concentration after shock wave treatment